Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00145184
Status:
TERMINATED
Last Update Posted:
2015-03-31
First Post:
2005-09-02
Brief Title:
Effect of Multivitamin Supplements on Clinical and Immunological Response in Childhood Tuberculosis
Sponsor:
Harvard School of Public Health HSPH
Organization:
Harvard School of Public Health HSPH
Study Overview
Official Title:
Effect of Multivitamin Supplements on Clinical and Immunological Response in Childhood Tuberculosis
Status:
TERMINATED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to see whether children who take vitamins along with the standard medicine for tuberculosis TB recover better and quicker than children who take only the standard medicine for TB Four hundred children ages 6 weeks-5 years who have been diagnosed with tuberculosis will be enrolled They will be followed for 2 months after treatment for TB Study procedures may include blood draws Tuberculin Skin Tests body measurements gastric aspirates removal of stomach fluid physical exams and questionnaires This study will occur in Tanzania
Detailed Description:
Tuberculosis TB remains the single most common infectious disease cause of mortality worldwide with evidence that support nutritional status may be associated with poor outcomes in TB patients Data from observational and limited intervention studies support the hypothesis that nutritional supplementsmicronutrients may be beneficial as well as potential treatments in TB The effect of micronutrient status will be examined in the context of a double blinded placebo controlled randomized trial 400 tuberculosis patients age 6 weeks to 5 years will be randomized to receive either multi-micronutrients or placebo from the start of their anti-TB therapy through 2 months of their anti-TB therapy The primary objective is to evaluate the efficacy of a multivitamin supplement containing vitamins B C and E on weight gain in childhood tuberculosis at 2 months after start of anti-tuberculosis therapy Secondary objectives are to evaluate the efficacy of a multivitamin supplement containing vitamins B C and E on clearance of chest x-ray in childhood tuberculosis at 2 months after start of anti-tuberculosis therapy compare the treatment arms with respect to the following immunological parameters ex-vivo lymphocyte proliferation cytokines production including IL-2 IL-12 TNF - alpha INF-gamma and CD4 and CD8 T-lymphocyte counts at 2 months after start of anti-tuberculosis therapy assess the validity of Tuberculin Skin Test TST for the diagnosis of childhood tuberculosis in a population with high BCG coverage and HIV prevalence assess the validity and feasibility of using microscopic observation broth drug susceptibility MODS assay of sputum and gastric aspirates in the diagnosis of childhood tuberculosis correlate the above-mentioned immunological markers IL-2 IL-12 INF-gamma and TNF-alpha with weight gain and chest x-ray at 2 months after start of anti-tuberculosis therapy and compare the immunological response to a supplement containing vitamins B C and E in childhood tuberculosis patients with and without HIV infection The endpoints of interest include immunological parameters like CD4 T lymphocyte count and clinical outcomes such as weight gain and resolution of chest x-ray after 2 months anti-TB therapy Researchers will also examine the utility of these immune response parameters as surrogate markers for treatment efficacy in TB irrespective of nutritional and other risk factors
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None